Xicil 1500 mg powder for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

XICIL 1500 mg powder for oral solution EFG

Glucosamine sulphate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.

• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What XICIL is and what it is used for
2. What you need to know before you take XICIL
3. How to take XICIL
4. Possible side effects
5. How to store XICIL
6. Contents of the pack and other information

1. What XICIL is and what it is used for

XICIL belongs to a group of medicines called other non-steroidal anti-inflammatory and antirheumatic agents.

XICIL is indicated for the relief of symptoms caused by mild to moderate knee osteoarthritis.

2. What you need to know before taking XICIL

Do not take XICIL

• if you are allergic (hypersensitive) to glucosamine or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to shellfish, as glucosamine is derived from shellfish.

Warnings and precautions

• if you have impaired glucose tolerance. More frequent monitoring of blood sugar levels may be necessary when starting treatment with glucosamine.
• if you have any risk factors for heart or arterial diseases, as increases in cholesterol levels have been observed in some patients treated with glucosamine.
• if you have asthma. When starting treatment with glucosamine, be aware that symptoms may worsen.
• if you have kidney or liver problems.

You should consult your doctor to rule out the presence of other joint diseases for which alternative treatment should be considered.

Children and adolescents

Do not take XICIL if you are under 18 years of age.

Other medicines and XICIL

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Caution is recommended if XICIL is administered in combination with other medicines, especially:

• Certain types of medicines used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and flindione). The effect of these medicines may be enhanced when used together with glucosamine. Therefore, patients receiving these combinations should be monitored more closely when starting or stopping glucosamine treatment.

• Antibiotics such as tetracycline.

Taking XICIL with food and drink

Dissolve the contents of the XICIL sachet in a glass of water and take once daily, preferably with meals.

Pregnancy, breastfeeding, and fertility

XICIL should not be used during pregnancy.

Use of glucosamine is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

No studies have been conducted on the effects of XICIL on the ability to drive and operate machinery. However, if you experience dizziness or drowsiness while taking XICIL, you should not drive or operate machinery (see section 4, "Possible side effects").

XICIL contains sodium, sorbitol, and aspartame

This medicine contains 151 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 7.6% of the maximum daily intake of sodium recommended for an adult.

This medicine contains 2028.5 mg of sorbitol per sachet.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

This medicine contains 2.5 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take XICIL

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose according to your condition.

Method of administration and dosage

The usual starting dose is one sachet (dissolved in a glass of water) once daily, preferably with meals.

For oral use.

Duration of treatment

Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be apparent until after several weeks of treatment and, in some cases, even longer. If you do not experience symptom relief within 2–3 months, consult your doctor or pharmacist, as alternative treatments may need to be considered.

If you take more XICIL than you should

If you take more XICIL than you should, or if someone else or a child takes this medicine, inform your doctor or pharmacist.

Signs and symptoms of overdose with glucosamine include headache, dizziness, confusion, joint pain, nausea, vomiting, diarrhoea or constipation. Do not continue taking XICIL at the first sign of any of the symptoms listed above.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take XICIL

Do not take a double dose to make up for missed doses.

If you stop treatment with XICIL

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

You must stop taking glucosamine and seek immediate medical attention at your doctor's office or nearest hospital if you experience any of the following symptoms:

• Swelling of the lips, face, tongue, or throat
• Difficulty swallowing or breathing
• Skin rash or hives

These symptoms may indicate that you are having a severe allergic reaction to this medicine.

The most frequently observed adverse effects are:

Common (may affect up to 1 in 10 people)

• Headache
• Fatigue
• Nausea
• Abdominal pain
• Indigestion
• Diarrhea
• Constipation

Uncommon (may affect up to 1 in 100 people)

• Skin rash
• Itching
• Redness
• Vomiting

Frequency not known (cannot be estimated from available data)

• Dizziness
• Worsening of asthma symptoms
• Swelling in ankles, legs, and feet
• Urticaria
• Increased cholesterol levels and worsening of blood glucose levels in patients with diabetes mellitus

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via Spain's national reporting system: “Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano” (Spanish System for Pharmacovigilance of Human Medicines): https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of XICIL

This medicine does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and packaging after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of XICIL

The active substance is glucosamine. Each sachet of XICIL contains 1,500 mg of glucosamine sulfate as glucosamine sulfate sodium chloride complex, equivalent to 1,178 mg of glucosamine.

The other components are: aspartame (E-951), sorbitol (E-420), sodium, citric acid, and macrogol 4000.

Appearance of the product and contents of the pack

The powder is white, crystalline, and odourless, and is packed in single-dose sachets.

Each pack contains 20 or 30 single-dose sachets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

The Netherlands

Manufacturer

Rottapharm, Ltd.

Damastown Industrial Park

Mulhuddart, Dublin 15

Ireland

or

SIGMAR ITALIA S.r.l.

Via Sombrero, 11

24011 – Almè (Bergamo) – Italy

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Date of the most recent revision of this leaflet: October 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es